510(k) · Cleared
ClearedEUSRA RF Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starmed Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 4, 2018 as substantially equivalent to K150029 (Emcision, Ltd., 2015) after a 117-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Sep 4, 2018
- Review
- 117 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945531 (1995). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945531 Blade ElectrodeE & M Engineering, Inc. · 1995
- 3 generations backK994075 Geiger Disposable Electrosurgical Electrode, Model 435Geiger Medical Technologies, Inc. · 1999
- 2 generations backK123061 Ace Monopolar AttachmentBioeconeer, Inc. · 2013
- 1 generation backK150029 Habib EUS RFAEmcision, Ltd. · 2015
- This deviceK181249 EUSRA RF ElectrodeStarmed Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK240932 HybridTherm SystemErbe Elektromedizin GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK251108 Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945531 | Blade Electrode | E & M Engineering, Inc. | 1995 | — |
| −3 | K994075 | Geiger Disposable Electrosurgical Electrode, Model 435 | Geiger Medical Technologies, Inc. | 1999 | — |
| −2 | K123061 | Ace Monopolar Attachment | Bioeconeer, Inc. | 2013 | — |
| −1 | K150029 | Habib EUS RFA | Emcision, Ltd. | 2015 | — |
| 0 (this device) | K181249 | EUSRA RF Electrode | Starmed Co., Ltd. | 2018 | — |
| +1 | K240932 | HybridTherm System | Erbe Elektromedizin GmbH | 2024 | — |
| +2 | K251108 | Erbe ESU Model VIO® 3n with Accessories | Erbe Elektromedizin GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150029 | Habib EUS RFASummary page 4…Product Code: GEI, JOS Device Class: 2 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] 510(k) Number: K150029 Applicant: EMcision LTD. Model Name: Habib EUS RFA 6700 Common Name… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240932 | HybridTherm System | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K240932 (Erbe Elektromedizin GmbH, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K150029.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The EUSRA RF Electrode is indicated for coagulation and ablation of soft tissue when used in conjunction with
compatible radio frequency generator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181249: EUSRA RF Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181249
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026